FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAGULATION REFERENCE PLASMA, NORMAL
K Number: K932145
·
Decision Oct 18, 1993
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
19
Applicant Total
39
Review Days
167
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Basic Information
- Device Name
- COAGULATION REFERENCE PLASMA, NORMAL
- K Number
- K932145
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Diagnostic Corp.
- Date Received
- May 4, 1993
- Decision Date
- October 18, 1993
- Product Code
- GIZ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GIZ | Plasma, Control, Normal | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GIZ), ordered by most recent decision date.
STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; FIBRINOGEN CONTROL-NORMAL, LOW
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CONTROL PLASMA N
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